Don Tracy, Associate Editor

A new study found that among 2,200 patients with irritable bowel diseases, 63% encountered financial barriers that led to missed doses of medication.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways that digital passports can help ensure patients receive the correct medication.

Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses innovations in label design that could lead to improved patient outcomes and less medical errors.

Under terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat frontotemporal dementia with progranulin mutations.

Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses scenarios where unclear labeling led to challenges for patient outcomes.

Under the agreement, AstraZeneca will be granted access to CSPC's small molecule candidate, YS2302018, with the goal of treating dyslipidemia and cardiovascular disease.

Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways to ensure that product labels are easily understood universally.

Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

Under terms of the deal, Philogen will complete clinical trials for Fibromun, seek approval, and handle manufacturing, with Sun Pharma leading global commercialization.

Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.

Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.

New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.

CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.

Partnership is expected to leverage Amneal’s global manufacturing and product development experience and Metsera’s portfolio of ultra-long acting injectables and oral nutrient-stimulated hormone analogs.

The application for Priority Review of Enhertu was supported by positive results from the DESTINY-Breast06 Phase III trial, which demonstrated that Enhertu reduced the risk of disease progression or death by 37% in patients with HER2-low or HER2-ultralow metastatic breast cancer.

Flyrcado is the first positron emission tomography myocardial perfusion imaging agent of its kind designed for the detection of coronary artery disease.

Designed for cataract patients, the TECNIS Odyssey aims to reduce the need for glasses by offering a full range of precise vision at all distances.

Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.

Landmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia in decades.

A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid overdose for patients with type 2 diabetes compared to other antidiabetic medications.

Tagrisso was approved under a Priority Review based on the pivotal LAURA Phase III trial in adults with unresectable stage III epidermal growth factor receptor-mutated non-small cell lung cancer.

Rybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by more than 50% in patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer, according to Johnson & Johnson.

Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.

Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when Keytruda was added to chemotherapy in patients with unresectable advanced or metastatic malignant pleural mesothelioma.